Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy

NCT ID: NCT01251354

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BN83495

Group Type: EXPERIMENTAL

BN83495

Intervention Type: DRUG

1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

Interventions

BN83495

1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of written informed consent prior to any study related procedures.
• postmenopausal or ovariectomised female patient over 18 years of age.
• histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
• patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
• patient has at least one measurable disease site (RECIST criteria version 1.1)

Exclusion Criteria

• patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
• patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
• patient was treated with any other investigational agent within the 3 weeks before study entry.
• patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Dept of Obstetrics and Gynecology, Medical College of Georgia

Augusta, Georgia, United States

Division of Gynecologic Oncology, University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Crozer Chester medical Center

Upland, Pennsylvania, United States

London Health Sciences Centre, University of Western Ontario

London, Ontario, Canada

Department of Oncology, Ottawa Cancer Center

Ottawa, Ontario, Canada

Dept of Obstetrics and Gynecology, Princess Margaret Hospital

Toronto, Ontario, Canada

CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique

Montreal, Quebec, Canada

Department of Oncology, McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

X-52-58064-007

Identifier Type: -

Identifier Source: org_study_id